(204 days)
The LED Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.
The LED Eye Perfector, model: EY-36A and EY-36B is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat wrinkles within the periorbital region. The device uses four types of LEDs, and for model EY-36A: 605 nm, 633 nm, 660nm, 830 nm, for EY-36B: 605 nm, 625 nm, 660nm, and 880 nm. The treatment time can be controlled by the user, or automatically shut off within a set time. The LED Eye Perfector components contain the main unit device, charging base, USB charging cord, velcro straps and goggles. There is a total of 40 LEDs to provide a power intensity of about 65 mW/cm². The user wears the device on their eye area for the treatment, and the device will shut down automatically after a 3-minute after finishing treatment. There are no differences between the two models other than the output wavelength.
The provided 510(k) summary for the LED Eye Perfector device (K221444) does not contain information about studies measuring the device's performance against clinical acceptance criteria. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and adherence to safety standards, rather than proving direct clinical efficacy or performance against specific metrics like sensitivity or specificity.
The "Test Summary" section (page 7) lists various safety and performance standards (e.g., electrical safety, electromagnetic compatibility, biocompatibility) to which the device was evaluated. These are engineering and safety tests, not clinical performance studies for efficacy in treating wrinkles.
Therefore, I cannot fulfill the request to describe acceptance criteria and study results related to clinical performance because the provided document does not include such information.
To elaborate on the specific points requested:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on compliance with general safety and electrical standards, not on clinical performance metrics like "wrinkle reduction percentage" or "satisfaction rates."
- Sample sizes used for the test set and the data provenance: Not applicable for clinical performance. The "test set" in this document refers to the device itself undergoing engineering and safety evaluations, not a patient cohort.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical efficacy is not discussed.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an LED-based treatment, not an AI diagnostic or assistance tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a therapeutic device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical efficacy. The "ground truth" implicitly used for the safety and engineering tests is compliance with the specified international standards.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a Class II medical device based on engineering and safety standards, and comparison to legally marketed predicate devices. It does not include data from clinical performance studies against specific acceptance criteria for wrinkle reduction.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.